Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Process performance in bioreactors is strongly influenced by the efficiency of bulk fluid mixing and the oxygen mass transfer coefficient (kLa). The success of traditional stainless steel STR systems lies in their direct impeller driven agitation that can deliver a wide range of specific power inputs to the fluid. The Allegro™ range of single-use stirred tank bioreactors has adopted this direct driven impeller technology, which allows a wide range of specific power inputs to be achieved. In addition, modifications to current design features utilized with other single-use bioreactor technologies in the market place today, have been implemented for increased ease of use and process assurance.

This white paper discusses how the Allegro STR range has been designed to provide a predictable scale-up performance modeling, therefore, the comparison of the mixing and mass transfer capabilities across the bioreactor range is presented with consistency from reactor to reactor at specified volume sizes. This information can help significantly in the selection of operating parameters during process transfer, including scale-up and scaledown, from bench-scale and stainless steel reactors. This leads to a reduction in the time required for additional development that may be needed for internal engineering performance modeling, and aids with conceptual understanding of how the cell line may perform during the process. This information can help significantly in the selection of operating parameters during process transfer, including scale-up and scale-down, from bench-scale and stainless steel reactors.